A medicine’s ePI ( Electronic Product Information) is regulated, scientifically validated information to assist healthcare professionals in prescribing and dispensing, and informs patients and consumers about their medicine and its safe use. Thus, trusted access and understanding of up-to-date product information on medicines when and where it is needed is extremely important. In Europe, the EMA in collaboration with Heads of Medicines Agencies in member states and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU.
The vision of the Vulcan HL7 accelerator is to connect clinical research and healthcare bringing together stakeholders across the translational and clinical research community in order to bridge existing gaps, strategically connecting industry collaboratives, maximize collective resources, and deliver integrated tools and resources.
The HL7® Structured Product Labelling standard (SPL) used by FDA to present medicinal product information is well known.. The European Medicine’s Agency (EMA) has Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) formats for electronic product information (ePI).
Earlier this summer, EMA released the first version of the Draft ePI Application Program Interface (API) specification in HL7® FHIR® that was open for consultation until the end of July. During the month of July 2021, a series of webinars and hands on workshops helped stakeholders get acquainted with the standard using an experimental FHIR server hosted by EMA.
The upcoming HL7® FHIR® connectathon will explore more specific consumer centered use cases that make use of the specification in the context of the larger eHealth ecosystem. These use cases are linked the Gravitate Health project.
The Gravitate Health project (www.gravitatehealth.eu), under the Innovative Medicines Initiative, explores how to use the ePI standard in conjunction with the HL7® FHIR® International Patient Summary (IPS) and other services such as those under myHealth@EU or EMA’s own SPOR implementation of ISO IDMP, to increase access, understanding, adherence, and safe use of medicines. UNICOM provides a major contribution to the prcatical implementation of the ISO-IDMP standard.
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-eu-common-standard-electronic-product-information-human-medicines-epi_en.pdf
If you are interested in joining the FHIR Connecthon ePI track do not hesitate to contact us. We are looking for app developers, electronic health record vendors, business developers, software engineers interested in developing ideas and solutions!
Here are some resources to look at:
https://confluence.hl7.org/pages/viewpage.action?pageId=120095544&src=contextnavpagetreemode
https://confluence.hl7.org/display/VA/Vulcan+Accelerator+Home
The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.
